NCT01562743

A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome

An Open-label Long-term Extension Trial From Late Phase II of SPM 962 (243-07-003) in Patients With Restless Legs Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The aims of the trial are to assess the safety and the efficacy of SPM 962 following once-a-daily transdermal administration within a range of 2.25 to 6.75 mg/day in Japanese patients with restless legs syndrome (RLS) in a multi-center, open-label trial. The maximum treatment period is 53 weeks. The trial is an extension trial from the precedent 6-week, double-blind, randomized, placebo-controlled, parallel-group comparative trial(243-07-003). The trial is also for an exploratory investigation of incidence of augmentation, the most problematic complications in dopaminergic treatment.

Conditions

• Idiopathic Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	SPM 962	Tansdermal patch

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2012-03-26
• Last updated: 2014-04-23
• Results posted: 2014-04-23